Percutaneous access devices are employed to establish a continuous connection or pathway, generally by means of an appropriate conduit such as a catheter, through an unnatural opening through the skin of a patient to facilitate external access to the body's interior. The conduit may connect internally, for example, to an internal organ, to a prosthetic device, to a blood vessel or nerve, to muscle, tendon, or bone, or merely terminate to one of the body's cavities. The external connection may be used for a variety of purposes such as ingress of energy, fluids or drugs, removal of fluids, or for attachment of a prosthetic device to bone, muscle, or tendon. A fundamental problem confronted in the use of percutaneous access devices is that infection can frequently occur because it has not generally been possible to obtain an adequate seal between the skin and the conduit to prevent the ingress of infection-causing agents through the opening in the skin. In order to minimize this problem and to avoid other problems such as marsupialization or sinus tract formation caused by efforts of the epidermus to close the unnatural opening, it has been proposed to utilize a percutaneous access device having a peridermal component on the conduit, on the surfaces of which skin cells from the patient have been cultured and are adherent.
One manner in which the foregoing problems have been overcome or minimized is by the use of a peridermal component designed to be implanted immediately beneath the skin and having a surface provided with a cell-cultured adherent fibroblast coating. Such coating is cultured on a nanoporous surface provided on said peridermal component in accordance with the teachings of U.S. Pat. No. 4,634,422. The term "nanoporous" is intended to have the same meaning as defined in said patent.
A critical step in the formation of infection resistant cell cultured percutaneous leads is the step of growing and maintaining a viable, undamaged layer of cells from a sample of the patients skin. It has hithertofore been difficult to transport and handle the device after cell-culturing while maintaining cleanliness and sterility, and without damage to the cell layer. Hithertofore the cell culturing of the nanoporous component has been completed before assembly to the conduit component. Subsequent assembly of the cultured component is difficult because of the challenges associated with maintaining sterility or asceptic conditions while at the same time attempting to neither disturb the cultured cells nor to allow them to dry out. It has also been difficult to achieve tight, secure, and void-free bonding of the cell cultured component to the conduit component. Mechanical interlocking has hithertofore been unreliable, and the use of glues or adhesives precluded because the cell-culture nanoporous component must be kept wet, most glues or adhesives are cytotoxic, and because of the drying of the cell-culture layer during the time required for the bonding to become secure.